Language During Inhalational Induction

Not Applicable

Recruiting

• Conditions: Anesthesia; Adverse Effect; Emergence Delirium
• Interventions: Behavioral: Standard/common language during induction; Behavioral: Positive language during induction

• Registration Number: NCT06324955
• Lead Sponsor: Boston Children's Hospital

Brief Summary

The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Study Start: 2024-04-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• ASA 1 and 2 (Healthy Patients)
• Non-emergent cases
• 5-10 year olds
• Patients receiving inhalational induction

Exclusion Criteria

• Non-English speaking
• History of prior inhalational inductions
• Hearing difficulty
• Behavioral difficulty (Autism, Oppositional Defiant Disorder)
• Patients receiving premedication other than midazolam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Common/Standard Language Group	Standard/common language during induction	-
Positive Language Group	Positive language during induction	-

Primary Outcome Measures

Name	Time	Method
Induction compliance	Through Study Completion about 1 day	Compliance of children during mask induction as measured by the Induction Compliance Checklist (ICC) from the time patient enters the operating room until loss of lid reflex

Secondary Outcome Measures

Name	Time	Method
Verbal refusal of mask	Through Study Completion about 1 day	Patient verbal expression of refusal of the mask during start of induction until loss of lid reflex
Length of induction	Through Study Completion about 1 day	Time from start of induction to loss of lid reflex

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States